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A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)

NCT03395210

CompletedPhase 2

Sponsor: Principia Biopharma, a Sanofi Company

Conditions: Immune Thrombocytopenia

Interventions: Rilzabrutinib

Countries: United States, Australia, Bulgaria, Canada, Czechia, Netherlands, Norway, United Kingdom

This was a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count \<30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. The dose-finding portion of the study was completed. Part B treatment dose was 400 mg twice daily.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male or female patients, aged 18 to 80 years old
* Immune-related ITP (both primary and secondary)

Exclusion Criteria:

* Pregnant or lactating women
* Current drug or alcohol abuse
* History of solid organ transplant
* Positive screening for HIV, hepatitis B, or hepatitis C
Locations (31)
  • Peoria, Illinois, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Midland, Michigan, United States
  • New York, New York, United States
  • Greenville, North Carolina, United States
  • Seattle, Washington, United States
  • Canberra, Australian Capital Territory, Australia
  • Sydney, New South Wales, Australia
  • Woolloongabba, Queensland, Australia
  • Clayton, Victoria, Australia
  • Parkville, Victoria, Australia
  • Perth, Western Australia, Australia
  • Pleven, Bulgaria
  • Sofia, Bulgaria
  • Varna, Bulgaria
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Brno, Czechia
  • Hradec Králové, Czechia
  • Ostrava - Poruba, Czechia
  • Prague, Czechia
  • Rotterdam, Netherlands
  • The Hague, Netherlands
  • Bergen, Norway
  • Grålum, Norway
  • Leicester, Leicestershire, United Kingdom
  • London, London, City of, United Kingdom
  • London, London, City of, United Kingdom
  • + 1 more on CT.gov